2018 Section 5 - Rhinology and Allergic Disorders

Reprinted by permission of Int Forum Allergy Rhinol. 2014; 4(5):381-389.

OR I G I NAL ART I CLE

Steroid-eluting sinus implant for in-office treatment of recurrent nasal polyposis: a prospective, multicenter study Franc¸ ois Lavigne, MD 1 , Steven K. Miller, MD 2 , Andrew R. Gould, MD 3 , Brent J. Lanier, MD 4 and J. Lewis Romett, MD 5

Background: Treatment options for chronic rhinosinusi- tis with recurrent polyposis (CRSwNP) a er endoscopic sinus surgery (ESS) are limited, and include frequent use of systemic steroids and revision surgery. A bioabsorbable, steroid-eluting implant was studied for its ability to dilate sinuses obstructed by polyps and provide localized, con- trolled steroid delivery to reestablish sinus patency. This study assessed the initial feasibility, safety, and efficacy of steroid-eluting implants placed in the office se ing in pa- tients who were candidates for revision ESS. Methods: Prospective, multicenter study enrolling 12 pa- tients who had prior ESS but experienced recurrent poly- posis refractory to medical therapy. Implants were placed bilaterally under topical anesthesia in-office. Follow-up through 6 months included endoscopic grading, patient- reported outcomes (22-item Sino-Nasal Outcomes Test [SNOT-22]) and need for revision ESS. Results: Implants were successfully inserted in 21 of 24 (88%) ethmoid sinuses, resulting in 11 evaluable patients. No serious adverse events occurred. Within 1 month, mean bilateral polyp grade was reduced from 4.5 at baseline to 2.3 ( p = 0.008) and sustained through 6 months (2.33; 1 Department of Otolaryngology, Centre hospitalier de l’Universit ´e de Montr ´eal (CHUM), H ˆopital Notre-Dame, Montr ´eal, Qu ´ebec, Canada; 2 Intermountain ENT, Salt Lake City, UT; 3 Advanced ENT & Allergy, Louisville, KY; 4 Central California ENT, Fresno, CA; 5 Colorado ENT & Allergy, Colorado Springs, CO Correspondence to: Francois Lavigne, MD, FRCSC, Department of Otolaryngology, Centre hospitalier de l’Universit ´e de Montr ´eal (CHUM), H ˆopital Notre-Dame, 1560 Sherbrooke St. E., Montr ´eal, Qu ´ebec, H2L 4M1, Canada; e-mail: f.lavigne@videotron.ca Funding sources for the study: Intersect ENT provided funding for the investigation as well as administrative and logistical support in coordinating the study across the study sites. Potential conflict of interest: F.L. is a consultant, advisory board member, and minor shareholder at Intersect ENT. None of the other authors have anything to report. Received: 8 August 2013; Revised: 19 January 2014; Accepted: 23 January 2014 DOI: 10.1002/alr.21309 View this article online at wileyonlinelibrary.com.

p = 0.008). Mean SNOT-22 score was significantly im- proved from 2.19 at baseline to 0.90 within 1 month ( p = 0.001) and sustained to 6 months (1.03; p = 0.012). Sixty- four percent of patients were no longer revision ESS candi- dates at 6 months. Conclusion: The study provided initial clinical evidence of the feasibility, safety, and efficacy of in-office steroid- eluting implant placement in CRS patients with recurrent polyposis a er ESS. Although further studies are needed, the results suggest this therapy may provide a safe and ef- fective, office-based option for the treatment of obstruc- tive polyposis. C 2014 ARS-AAOA, LLC. Key Words: sinusitis; nasal congestion; nasal polyps; inflammation; functional endoscopic sinus surgery; FESS; corticosteroid; mometasone furoate; drug-eluting implant; bioabsorbable How to Cite this Article: Lavigne F, Miller SK, Gould AR, Lanier BJ, Rome JL. Steroid-eluting sinus implant for in-office treatment of re- current nasal polyposis: a prospective, multicenter study. Int Forum Allergy Rhinol. 2014;4:381–389. C hronis rhinosinusitis with nasal polyposis (CRSwNP) is a distinct subtype of CRS with an estimated preva- lence of 3% to 5%, with a greater burden of symptoms and a higher relapse rate after treatment, making this subtype more costly to manage. 1,2 Options for the management of CRSwNP are aggres- sive medical treatment, surgery, and combinations thereof. Patients who have been managed both medically and surgi- cally but continue to present with recurrent polyposis and CRS symptomatology represent 1 of the otolaryngologist’s most perplexing and challenging patient populations. This recidivism leads to repeated rounds of corticosteroid ther- apy, off-label strategies for attempting to deliver medica- tions to the sinus anatomy, or multiple revision surgeries. Although endoscopic sinus surgery (ESS) is now widely accepted for the treatment of inflammatory diseases of the paranasal sinuses, and particularly for patients with

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